Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00910325
Recruitment Status : Terminated (The alternative laparoscopic chole, has so little morbidity very few patients opt for a transvaginal approach when presented with the alternative)
First Posted : May 29, 2009
Last Update Posted : October 30, 2012
Information provided by (Responsible Party):
David W. Rattner, MD, Massachusetts General Hospital

Brief Summary:
To determine the feasibility, safety, and efficacy of a novel minimally invasive approach to cholecystectomy and to establish a description of this novel translumenal technique in humans at this institution.

Condition or disease Intervention/treatment Phase
Cholelithiasis Procedure: Laparoscopic-assisted transvaginal cholecystectomy Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
Study Start Date : November 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones
U.S. FDA Resources

Intervention Details:
    Procedure: Laparoscopic-assisted transvaginal cholecystectomy
    Trans-vaginal Cholecystectomy with Laparoscopic Assistance

Primary Outcome Measures :
  1. The safety and efficacy of the procedure [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Post-operative pain [ Time Frame: one year ]
  2. Time to return to work [ Time Frame: one year ]
  3. Time to return to daily activities [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   26 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Females who are postmenopausal or who no longer wish to bear children
  • Females >25 years old and <65 years old
  • Diagnosis of biliary disease requiring cholecystectomy
  • American Society of Anesthesiology (ASA) Class I or II
  • Females who are able to understand and willing to sign an informed consent document

Exclusion Criteria:

  • Pregnancy
  • BMI >= 30
  • Patients who are still interested in childbearing
  • Patients taking immunosuppressive medications or who are immunocompromised
  • Patients with acute cholecystitis or history of acute cholecystitis ( as defined by right upper quadrant pain with history of fevers and/or elevated white blood cell count and/or positive ultrasound findings, ie, gallbladder wall thickening or pericholecystic fluid)
  • Patients with suspicion of gallbladder cancer
  • Patients with history of previous open abdominal surgery
  • Patients with untreated common bile duct stones

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00910325

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: David W Rattner, MD Massachusetts General Hospital

Responsible Party: David W. Rattner, MD, Chief, Division of General and Gastrointestinal Surgery, Massachusetts General Hospital Identifier: NCT00910325     History of Changes
Other Study ID Numbers: 2008p001938
First Posted: May 29, 2009    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: October 2012

Keywords provided by David W. Rattner, MD, Massachusetts General Hospital:
Natural Orifice Surgery
Laparoscopic- Assisted

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical